Overview of Current COVID-19 Diagnostic Devices with FDA Emergency Use Authorization

Updated April 2, 2020 (added new EUA's and serology tests)

Please bookmark this page as I will continually update this information as additional EUA's are issued and new commercial diagnostic and serology kits are validated. 

Numerous COVID-19 in-vitro diagnostic devices have been submitted to FDA for Emergency Use Authorizations (EUA). The following table provides an up-to-date summary of all FDA EUA's.

There are also a number of SARS-CoV-2 diagnostic and serology tests that are in development or that have been distributed while manufacturers prepare an EUA submission for a test whose performance characteristics have already been validated. A current list of diagnostic and serology tests that fit into this category is provided after the EUA table. NOTE: the table should be viewed in landscape mode on smaller handheld devices.

Date EUA Issued	Supplier	Letter of Authorization	Fact Sheet  for Healthcare Providers	Fact Sheet  for Patients	Supplier Instructions or Package Insert	Other Info
04/01/2020	Ipsum Diagnostics, LLC	COV-19 IDx Assay	Healthcare Providers	Patients	EUA Summary	None
04/01/2020	Cellex Inc.	qSARS-CoV-2 IgG/IgM Rapid Test	Healthcare Providers	Patients	IFU	None
03/30/2020	QIAGEN GmbH	QIAstat-Dx Respiratory SARS-CoV-2 Panel	Healthcare Providers	Patients	IFU	None
03/30/2020	NeuMoDx Molecular, Inc.	NeuMoDx SARS-CoV-2 Assay	Healthcare Providers	Patients	IFU	None
03/27/2020	Abbott Diagnostics Scarborough, Inc.	ID NOW COVID-19	Healthcare Providers	Patients	IFU	None
03/27/2020	Luminex Molecular Diagnostics, Inc.	NxTAG CoV Extended Panel Assay	Healthcare Providers	Patients	IFU	None
03/26/2020	BGI Genomics Co. Ltd.	Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV	Healthcare Providers	Patients	IFU	None
03/25/2020	Avellino Lab USA, Inc.	AvellinoCoV2 Test	Healthcare Providers	Patients	EUA Summary	None
03/24/2020	PerkinElmer, Inc.	PerkinElmer New Coronavirus Nucleic Acid Detection Kit	Healthcare Providers	Patients	IFU	None
03/23/2020	Mesa Biotech Inc.	Accula SARS-Cov-2 Test	Healthcare Providers	Patients	IFU	None
03/23/2020	BioFire Defense, LLC	BioFire COVID-19 Test	Healthcare Providers	Patients	IFU	None
03/20/2020	Cepheid	Xpert Xpress SARS-CoV-2 test	Healthcare Providers	Patients	IFU for Labs IFU for Point-of-Care	None
03/20/2020	Primerdesign Ltd.	Primerdesign Ltd COVID-19 genesig Real-Time PCR assay	Healthcare Providers	Patients	IFU	None
03/19/2020	GenMark Diagnostics, Inc.	ePlex SARS-CoV-2 Test	Healthcare Providers	Patients	IFU	None
03/19/2020	DiaSorin Molecular LLC	Simplexa COVID-19 Direct assay	Healthcare Providers	Patients	IFU	None
03/18/2020	Abbott Molecular	Abbott RealTime SARS-CoV-2 assay	Healthcare Providers	Patients	IFU	None
03/17/2020	Quest Diagnostics Infectious Disease, Inc.	Quest SARS-CoV-2 rRT-PCR	Healthcare Providers	Patients	IFU	None
03/17/2020	Quidel Corporation	Lyra SARS-CoV-2 Assay	Healthcare Providers	Patients	IFU	Letter Granting EUA Amendment(s) (March 23, 2020)
03/16/2020	Laboratory Corporation of America (LabCorp)	COVID-19 RT-PCR Test	Healthcare Providers	Patients	EUA Summary	None
03/16/2020	Hologic, Inc.	Panther Fusion SARS-CoV-2	Healthcare Providers	Patients	IFU	None
03/13/2020	Thermo Fisher Scientific, Inc.	TaqPath COVID-19 Combo Kit	Healthcare Providers	Patients	IFU	None
03/12/2020	Roche Molecular Systems, Inc. (RMS)	cobas SARS-CoV-2	Healthcare Providers	Patients	IFU	None
02/29/2020	Wadsworth Center, New York State Department of Public Health's (CDC)	New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel	Healthcare Providers	Patients	IFU	Letter Granting EUA Amendment(s) (March 15, 2020)
02/04/2020	Centers for Disease Control and Prevention's (CDC)	CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)	Healthcare Providers	Patients	IFU	None

As stated in Section IV.C of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA does not intend to object to a commercial manufacturer's development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. As noted in the guidance, FDA believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. This policy does not apply to at home testing.

The commercial manufacturers listed below have notified FDA that they have validated and are distributing test kits as set forth in Section IV.C of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019. The FDA has not yet reviewed the validation of the tests of these manufacturers or issued EUAs for these manufacturers' tests and is including this list here to provide transparency regarding the notifications submitted to FDA.

        BD BioGx SARS-CoV-2 Reagents for BD MAX System
        Co-Diagnostics, Inc.

As stated in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:

• This test has not been reviewed by the FDA. 
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. 
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. 
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. This policy does not apply to at home testing. 

The commercial manufacturers and laboratories listed below have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019. The FDA has not reviewed the validation of tests offered by these developers, who will not be pursuing EUAs, and is including this list here to provide transparency regarding the notifications submitted to FDA.

• Assure Tech (Hangzhou) Co., Ltd.'s COVID-19 IgG/IgM Rapid Test Device
• Autobio Diagnostics' Anti-SARS-CoV-2 Rapid Test
• Beijing Decombio Biotechnology Co., Ltd. Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)
• Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgG Antibody Determination Kit
• Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgM Antibody Determination Kit
• Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgG/IgM Antibody Rapid Test Kit
• Beijing Kewei Clinical Diagnostic Reagent Inc. Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit
• Beijing O&D BIOTECH Co., LTD. Coronavirus disease(COVID-19) Total Antibody Rapid Test (Colloidal Gold)
• Beroni Group SARS-CoV-2 IgG/IgM Antibody Detection Kit
• BioMedomics, Inc. COVID-19 IgM-IgG Rapid Test
• BTNX, Inc. Rapid Response™ COVID-19 IgG/IgM Test Cassette
• Chembio Diagnostic Systems, Inc. DPP COVID-19 IgM/IgG System
• Core Technology Co., Ltd. CoreTest COVID-19 IgM/IgG Ab Test
• Coronacide™ COVID-19 IgM/IgG Rapid Test
• Diazyme Laboratories, Inc. Diazyme DZ-LITE SARS-CoV-2 IgG CLIA Kit
• Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-Cov-2 IgM CLIA Kit
• Eachy Biopharmaceuticals Co., Ltd. AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)
• EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgA)
• EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG)
• Guangzhou Wondfo Biotech Co., Ltd. SARS-CoV-2 Antibody Test
• Hangzhou AllTest Biotech Co., Ltd. AllTest 2019-nCoV IgG/IgM Rapid Test Cassette
• Hangzhou AllTest Biotech Co., Ltd. AllTest COVID IgG/IgM Rapid Test Dipstick
• Hangzhou Clongene Biotech Co., Ltd. Clungene COVID-19 IgM/IgG Rapid Test Cassette
• Hangzhou Biotest Biotech's COVID-19 IgG/IgM Rapid Test Cassette
• Hangzhou Realy Tech Co Ltd. 2019-nCOV IgG/IgM Rapid Test
• Hangzhou Testsealabs Biotecnology Co., Ltd One Step SARS-CoV2 (COVID-19) IgG/IgM Test
• Healgen Scientific, LLC. COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)
• INNOVITA (Tangshan) Biological Technology Co., Ltd. 2019-nCoV Ab Test (Colloidal Gold)
• Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold)
• Lifeassay Diagnostics (Pty) Ltd Test-it COVID-19 IgM/IgG Lateral Flow Assay
• Medical Systems Biotechnology Co., Ltd. Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit
• Nanjing Liming Bio-products Co.,Ltd SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit
• NanoResearch, Inc. NanoMedicina™ SARS-COV-2 IgM/IgG Antibody Rapid T
• Nantong Diagnos Biotechnology Co., Ltd. (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)
• Nirmidas Biotech, Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
• PCL Inc. COVID19 IgG/IgM Rapid Gold
• Phamatech Inc. COVID19 IgG/IgM Rapid Test
• Promedical COVID-19 Rapid Test {Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method)}
• SD Biosensor STANDARD Q COVID-19 IgM/IgG Duo
• Shanghai Eugene Biotech Co., Ltd. SARS-CoV2 (COVID-19) IgG/IgM Rapid Test
• Shenzhen Landwind Medical Co., Ltd COVID-19 IgG/IgM Rapid Test Device
• Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG
• Suzhou Kangheshun Medical Technology Co., Ltd SARS-CoV-2 IgG/IgM Rapid Test Cassette
• Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test
• Tianjin Beroni Biotechnology Co. Ltd SARS-CoV-2 IgG/IgM Antibody Detection Kit
• United Biomedical, Inc. UBI® SARS-CoV-2 ELISA
• VivaChek Biotech (Hangzhou) Co., Ltd. VivaDiag COVID-19 IgM/IgG Rapid Test
• Zhejiang Orient Gene Biotech, Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette
• Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgG Antibody Rapid Test Kit (Colloidal Gold Immunochromatography method)
• Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgM Antibody Rapid Test Kit (Colloidal Gold Immunochromatography method)
• Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography method)
• Zhongshan Bio-Tech Co. Ltd SARS-CoV-2 IgM/IgG (GICA)
• Zhuhai Encode Medical Engineering Co., Ltd Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device
• Zhuhai Livzon Diagnostics, Inc. Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)